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Paleolithic Diet and Exercise Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00360516
Recruitment Status : Completed
First Posted : August 4, 2006
Last Update Posted : June 29, 2011
Sponsor:
Information provided by:
University of California, San Francisco

Tracking Information
First Submitted Date  ICMJE August 2, 2006
First Posted Date  ICMJE August 4, 2006
Last Update Posted Date June 29, 2011
Study Start Date  ICMJE November 2005
Actual Primary Completion Date September 2007   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 28, 2011)
validation of algorithm to predict diet net acid load [ Time Frame: 1year ]
measuring 24-hour net acid and comparing this to the estimated diet acid load using one of several algorithms
Original Primary Outcome Measures  ICMJE
 (submitted: August 2, 2006)
validation of algorithm to predict diet net acid load
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 28, 2011)
effects of a "Paleolithic" diet on exercise capacity, vascular reactivity, lactate production during exercise, glucose and lipid profiles and [ Time Frame: 1 year ]
measuring VO2max, CO, BAR,
Original Secondary Outcome Measures  ICMJE
 (submitted: August 2, 2006)
effects of a "Paleolithic" diet on exercise capacity, vascular reactivity, lactate production during exercise, glucose and lipid profiles and
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Paleolithic Diet and Exercise Study
Official Title  ICMJE Paleolithic Diets, Exercise Physiology and Metabolism
Brief Summary If eating a "Paleolithic" diet helps improve these diseases, this would be the first step in both improving people's health as they get older as well as contributing to future national dietary guidelines for Americans.
Detailed Description

Because genetic evolutionary changes occur slowly in Homo sapiens, and because the traditional diet of Homo sapiens underwent dramatic changes within recent times, modern humans are better physiologically adapted to a diet similar to the one their hominid ancestors evolved on than to the diet typical of modern industrialized societies. The investigators developed a computational model to estimate the net acid load of diets from the nutrient composition of the diet's component ingredients, and suggest that the majority of these hominid diets yield a negative net acid load (that is, yield a net base load), in addition to being low in sodium chloride, high in potassium-containing fruits and vegetables, and low in saturated fats, with the majority of the non-animal-source calories coming from fruits and vegetables, not from acid-producing grains, separated fats and oils, starches and refined sugars. According to paleonutritionists, Homo sapiens' recent switch from their ancestral Paleolithic-type diet to the modern Western diet has contributed in a major way to so-called age-related diseases of civilization. The investigators hypothesize and will test whether:

  1. consuming a high-potassium, low-sodium, net base-producing "Paleolithic-type" diet, even in the short term, has detectable beneficial effects on cardiovascular physiology, serum lipid profiles, insulin sensitivity, and exercise performance; and
  2. their computational model predicts the measured negative net acid loads of a net base-producing "Paleolithic-type" diet, using steady-state values of renal net acid excretion as the measure of the diet net acid load (a.k.a., net endogenous acid production), which will be of value in constructing net-base producing diets for modern consumption.

The long term complications of the combination of high blood pressure, high blood sugar and high fat and cholesterol levels, sometimes called the "metabolic syndrome", has been termed the number one medical problem in modern society today. If eating a "Paleolithic" diet helps improve these diseases, this would be the first step in both improving people's health as they get older as well as contributing to future national dietary guidelines for Americans.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE Diet
Intervention  ICMJE Behavioral: metabolic (nutrient controlled) diet
metabolic (nutrient controlled) diet
Study Arms  ICMJE Not Provided
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 2, 2006)
10
Original Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 2007
Actual Primary Completion Date September 2007   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Age >= 18 years and <= 55 years
  • On no medications
  • Body mass index (BMI) between 18 and 29.9 kg/m2
  • Normal renal and hepatic function
  • Subjects who report moderate intensity exercising <= three times a week for 30 minutes or less, who then qualify by exercise testing with a VO2max at or below age- and gender-matched controls

Exclusion Criteria:

  • Subjects who must follow a specific diet
  • Subjects on any daily medications
  • Subjects unwilling to follow the diet specified
  • Subjects unable to do the exercise testing
  • Pregnant women
  • Subjects who are unable to understand the consent form.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 55 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00360516
Other Study ID Numbers  ICMJE H8748-27380-02
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party GCRC, UCSF
Study Sponsor  ICMJE University of California, San Francisco
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Lynda A Frassetto University of California, San Francisco
PRS Account University of California, San Francisco
Verification Date June 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP